Quality Risk Radar

“Risk-adapted Steering of Your Clinical Processes“

Quality Risk Radar (QRR) facilitates risk-based decision making by collecting and analyzing performance as well as transactional data, and by computing risk. QRR detects the potential deviations in quality via its two types of antennas: automated source system data feeds and web-based configurable questionnaires.

Consequently, the QRR functions as a support process for promoting patient safety and ensuring data integrity during drug development. Its cost-effective information delivery approach is simple and easily adopted by regional, country and study managers, clinical teams and monitors. Risks are quantifiable and can be associated with specific organizational activities, enabling targeted GCP consulting and support at the appropriate level. Its risk model facilitates a common method of aggregation within the risk landscape.

Benefits

Reduces operational costs by mitigating risks before they become actualized, e.g. avoid protocol amendments

Broad risk coverage of your clinical processes by an industry-tested, best-practice set of Key Risk Indicators (KRIs)

Increase productivity by using pre-configured Quality Risk Management (QRM) tools that incorporate business knowledge

Better risk-informed resource allocation due to regular measurement, calculation, analysis and communication of risks

Study Setup Assessment Dashboard

ii4sm’s Quality Risk Radar collects, structures, computes and reports on risk data to provide valuable decision support in clinical development.

The QRR consists of:

Risk Data Collection

Automated source system data feeds and configurable questionnaire framework for metrics of any risk entity in your enterprise.

Risk Assessor

Calculation and evaluation of the collected risk metrics.

Risk Reporter

Communication of risk assessments with the appropriate level of detail to clinical trial stakeholders.

Risk Mitigator

Facilitates the tracking and management of risks to quality such as compliance issues or performance deficits.

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